Laser Atherectomy for ST Elevation Myocardial Infarction
关键词
抽象
描述
The clinical result of catheter treatment in the patients with acute myocardial infarction in these several decades improved because of progress of early reperfusion therapy and stent treatment technique. However, the no-reflow phenomenon is still remaining as a problem, which is involved in a decrease in left ventricular function and worsening of prognosis. It is considered that the no-reflow phenomenon is induced by atherosclerotic and thrombotic emboli, endothelial dysfunction of capillary vessels, free radicals and cytokine. The treatment combining the peripheral protection and thrombus aspiration aiming at prevention of no-reflow is expected to reduce no-reflow and the infarct size and has been conducted on the patients with acute myocardial infarction. However, a lot of randomized studies have been conducted, so far, which do not lead to reduction of infarct size and improvement of survival rate, and the efficacy has not been demonstrated.
Some explanations have been suggested for this phenomenon:
1. The operation method of device is complicated, and it is difficult to acquire the treatment technique.
2. Giant thrombus and solid lesion could not be aspirated effectively.
3. A lot of randomized studies have not focused on the "patients with anterior descending lesion of thrombolysis in myocardial infarction (TIMI) grade 0/1, of which the time from onset to treatment is within 6 hours," considered to have the largest benefit of prevention of no-reflow.
In recent years in Japan, excimer laser coronary angioplasty (ELCA) has been used in the patients with acute coronary syndrome (ACS), and not only debulking of arteriosclerotic lesion but also thrombolytic effect have been reported. In the Camel trial and Utility of Laser for Transcatheter Atherectomy Multicenter Analysis around Naniwa (ULTRAMAN) registry, the efficacy and safety in ACS have been reported, but the infarct size has not been evaluated.
This time in this study, it is considered that verification whether or not ELCA is able to improve the myocardial salvage in anterior ST elevation myocardial infarction (STEMI) using myocardial scintigram (acute-phase BMIPP and chronic-phase TF) will provide the useful information helpful for selection of treatment to medical care staffs and patients for future patients suffering from ACS and will be able to contribute to further improvement of medical science and medical practice.
MRI will be performed twice at 5-9 days and at 6 months post index ST elevation myocardial infarction to assess myocardial damage and functional variables, which details will be described in the following outcome measurement section.
日期
| 最后验证: | 04/30/2019 |
| 首次提交: | 04/19/2019 |
| 提交的预估入学人数: | 05/09/2019 |
| 首次发布: | 05/14/2019 |
| 上次提交的更新: | 05/09/2019 |
| 最近更新发布: | 05/14/2019 |
| 实际学习开始日期: | 07/25/2018 |
| 预计主要完成日期: | 12/30/2020 |
| 预计完成日期: | 12/30/2030 |
状况或疾病
干预/治疗
Device: ELCA
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: ELCA On the antegrade delivery of the laser catheter after wiring, we used safe laser techniques and injected saline before and during the laser procedure at a 0.5 mm/sec catheter advancement rate. Whether to perform a retrograde laser method depended on each operator. After ablation by ELCA, patients undergo balloon dilation via standard techniques, and as appropriate, receive drug-eluting stent deployment. | Device: ELCA The excimer laser catheter is equipped with multiple optical fibers on the periphery of the guide wire lumen corresponding to 0.014 inch, which is used for the purpose of reperfusion of barrier site of coronary artery. The connector on the front side is connected with the CVX-300 laser generator, and the tip at the top contact directly with the lesion. The laser catheter consisting of multiple optical fibers transmits the energy in the ultraviolet region from the CVX300 laser generator to the blockage in the blood vessel. The ultraviolet energy is transmitted from the tip of laser catheter, transpires the fibrous, calcified and arteriosclerotic lesion by light, and enables reperfusion in the lesion. The laser catheter has appropriate hydrophilic coating and easily follows the inside of coronary artery. |
| No Intervention: non ELCA In non ELCA group, the conventional PCI procedure, including thrombus aspiration, POBA, and stent implantation was performed. The indication for aspiration was at the discretion of the physician based on angiographic, intravascular ultrasound, or optical coherence tomography/Optical Frequency-Domain Imaging. |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patients to whom PCI treatment for anterior STEMI is indicated [Main selection criteria] - First-episode anterior STEMI patients within 6 hours of onset that satisfy electrocardiogram criteria - Patients who are 21 years of age or older at the time of consent acquisition - Patient who the patient himself agreed in writing Exclusion Criteria: - Patients presenting cardiac shock at the time of visit - Patients whose target lesions are left main trunk, circumflex, right coronary artery, distal anterior descending branch - Patients who have TIMI 2, 3 at the initial imaging - Patients with a reference vessel diameter of 2.5 mm or less - Patients determined to lack consent ability for mental or other reasons - Patient who is judged inappropriate by research researcher or research sharing doctor The inclusion and exclusion criteria for the MRI will follow the main study, but in addition, will exclude following conditions. - Atrial fibrillation subject at the timing of MRI scan - Internally implanted devices such as pacemakers or ICDs - Subject that is allergic to Gadolinium, - Subject with claustrophobia - Pregnancy |
结果
主要结果指标
1. myocardial salvage (17 segment model) by SPECT [3 day to 6 month]
2. Myocardial Salvage index (17 segment model) by SPECT [3 day to 6 month]
次要成果指标
1. Myocardial scar amount assessment by MRI [5-9 days and 6 month]
2. Microvascular obstruction assessment by MRI [5-9 days and 6 month]
3. Myocardial salvage assessment by MRI [5-9 days and 6 month]
4. Ejection fraction assessment by MRI [5-9 days and 6 month]
5. Gray zone assessment by MRI [5-9 days and 6 month]
6. Left ventricular ejection fraction by TF scintigraphy at 6 months [5-7 month]
7. Left ventricular volume (ml) by TF scintigraphy at 6 months [5-7 month]
8. Left ventricular end-diastolic volume (ml) by TF scintigraphy at 6 months [5-7 month]
9. Left ventricular end-systolic volume (ml) by TF scintigraphy at 6 months [5-7 month]
10. Intra-stent tissue volume by OCT [at the end of procedure and 1-year]
11. Myocardial salvage [total perfusion defect (TPD) model] by SPECT [3 day to 6 month]
12. Myocardial salvage index (%) [total perfusion defect (TPD) model] by SPECT [3 day to 6 month]
13. Major adverse cardiovascular events (MACE) at 12 months [12 months]
14. Major adverse cardiovascular events (MACE) at 36 months [36 months]
15. Major adverse cardiovascular events (MACE) at 60 months [60 months]
16. Cardiac death at 12 months [12 months]
17. Cardiac death at 36 months [36 months]
18. Cardiac death at 60 months [60 months]
